Long COVID-19 Infections and Infestations
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age =18 years, AND 2. English or Welsh speaker or have access to someone who can act as a translator 3. Consulted with their GP to rule out serious complications or the need for further investigation in relation to persistent symptoms following COVID-19 infection, AND 4. Experience persistent illness (at least one long COVID symptom for 12 weeks or longer, AND 4.1 Positive SARS-CoV-2 PCR or antigen test (positive COVID19 test) during the acute phase of illness, OR 4.2 Positive SARS-CoV-2 antibody test (positive COVID-19 antibody test) at any time point in the absence of SARS-CoV-2 ( COVID-19) vaccination history, OR 4.3 Loss of sense of smell or taste during the acute phase in the absence of any other identified cause, OR 4.4 Symptoms consistent with SARS-CoV-2 ( COVID-19) infection during the acute phase and high prevalence of COVID-19 at time and location of onset, OR 4.5 At least one symptom consistent with SARS-CoV-2 ( COVID-19) infection during the acute phase AND close contact of a confirmed case of COVID-19 around the time of onset
Exclusion criteria
Exclusion criteria: 1. Any co-morbidities which are progressive or requiring palliative treatment. 2. Have been hospitalised for treatment of COVID-19 symptoms, during the acute phase of COVID illness. 3. Are currently participating in any COVID intervention trial (including contributing to the LISTEN co-design activities).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The impact of the LISTEN intervention on routine activities is assessed using the routine activities scale domain of the Oxford Participation and Activities Questionnaire (Ox-PAQ) at baseline and 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the impact of the LISTEN intervention on emotional well-being as assessed by the relevant domain sub-scale of the Ox-PAQ, at baseline and 3 months. 2. To evaluate the impact of the LISTEN intervention on social engagement as assessed by the relevant domain sub-scale of the Ox-PAQ, at baseline and 3 months. 3. To evaluate the impact of the LISTEN intervention on health-related quality of life as assessed by the Short Form (12) Health Survey, at baseline and 3 months. 4. To evaluate the impact of the LISTEN intervention on fatigue as measured by the Fatigue Impact Scale (FIS) at baseline and 3 months. 5. To assess health-related quality of life expressed as utility using the EQ-5D-5L questionnaire, at baseline, 6 weeks and 3 months. 6. To gather information on healthcare resource use using an adapted client service receipt inventory at baseline, 6 weeks and 3 months. 7. To assess the cost-effectiveness of the LISTEN intervention using an adapted client service receipt inventory at baseline, 6 weeks and 3 months. 8. To explore key anticipated mediators of intervention outcome (namely self-efficacy in the context of COVID-19) using the generalised self-efficacy scale (GSES) with additional context-specific questions at baseline and 3 months 9. To conduct a theory-driven detailed process evaluation within the trial using validated implementation scales to assess intervention acceptability, appropriateness and feasibility (through use of the AIM, IAM and FIM questionnaires, respectively) for a selection of intervention users at 3 months and providers at 3 months and 6 months into recruitment. | — |
Countries
United Kingdom, Wales